The FDA approval is based on results from the Phase 3 PAPILLON study, which showed Rybrevant plus chemotherapy reduced the risk of disease progression or death by 61% versus chemotherapy alone in patients with previously untreated NSCLC
The FDA approval is based on Phase 3 PAPILLON study. (Credit: Myriams-Fotos from Pixabay)
Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for Rybrevant (amivantamab-vmjw) plus chemotherapy (carboplatin-pemetrexed) to treat a type of non-small cell lung cancer (NSCLC).
Rybrevant is a human bispecific antibody targeting EGFR and MET with immune cell-directing activity, approved in the US, Europe and in other markets worldwide.
The combination is indicated for the treatment of patients with metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, detected by an FDA-approved test.
The FDA approval converts the accelerated approval of Rybrevant, granted in May 2021, to a full approval based on the confirmatory Phase 3 PAPILLON study.
Johnson & Johnson Innovative Medicine solid tumors clinical development vice president Kiran Patel said: “We are redefining care for patients with non-small cell lung cancer by advancing innovative regimens that can be used early, with the goal of extending survival.
“RYBREVANT plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations.
“We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio.”
The FDA approval is based on positive results from the Phase 3 PAPILLON study.
The study showed that Rybrevant plus chemotherapy resulted in a 61% reduction in the risk of disease progression or death compared to chemotherapy alone.
It also showed that the combination improved objective response rate (ORR) and progression-free survival (PFS).
Furthermore, the National Comprehensive Cancer Network (NCCN), based on the study data, has updated guidelines to include Rybrevant plus chemotherapy as a preferred therapy for NSCLC with EGFR exon 20 insertion mutations.
Study investigator Joshua Sabari said: “When aiming for the best possible treatment outcomes, a targeted approach should be used in the first line for patients with EGFR exon 20 insertion mutations, as this is a commonly applied practice for patients with NSCLC harbouring other molecular driver alterations.
“The results observed in the PAPILLON study showed significant improvement in progression-free survival, supporting the use of this regimen as the potential standard-of-care in the first-line treatment of these patients.”